NCT01322152已完成2 期
Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Rate of Diarrhea
研究概览
简要总结
The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.
详细描述
Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Histologically confirmed colorectal cancer
- •Age 18-70 years old
- •Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
- •Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Life expectancy of more than 3 months.
- •Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 100×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, AKP < 4×ULN
排除标准
- •Pregnant or lactating patients
- •Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- •Active or uncontrolled infection
- •Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- •Patients could not swallow the tablets
- •Concomitant with brain metastases
研究组 & 干预措施
wXELIRI regimen
Experimental
干预措施: irinotecan, capecitabine (Drug)
结局指标
主要结局
Rate of Diarrhea
时间窗: eight weeks
次要结局
- Progression free survival(eight weeks)
- Response rate(eight weeks)
- Disease control rate(eight weeks)
- Overall survival(eight weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(eight weeks)
研究者
研究点 (1)
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